K961993 is an FDA 510(k) clearance for the BIRTHDAY KIT (OBSTETRICAL DELIVERY KIT). This device is classified as a Labor And Delivery Kit (Class II - Special Controls, product code MLS).
Submitted by Devon Industries, Inc. (Chatsworth, US). The FDA issued a Cleared decision on July 3, 1996, 43 days after receiving the submission on May 21, 1996.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4530. This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
| 510(k) Number | K961993 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 1996 |
| Decision Date | July 03, 1996 |
| Days to Decision | 43 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | Statement |
| Product Code | MLS — Labor And Delivery Kit |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 884.4530 |
| Definition | This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Www.fda.gov/cdrh/ode/convkit.html. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance |